This application claims benefit of provisional application Ser. No. 61/057,177 filed May 29, 2008.
The present invention relates generally to intravascular balloon catheters used to conduct venograms, angiograms and angioplasties, and more particularly, to a device that facilitates such procedures using a single catheter.
The blockage of arterial blood vessels, i.e. atherosclerosis, is a common disorder that can have serious consequences. The narrowing or blockage of arteries can result in potentially fatal conditions such as coronary heart disease and myocardial infarctions. Other damaging narrowing or blockages can occur in non-coronary arteries and veins throughout the body. The blockages resulting from such disorders can lead to further complications where permanent injury or death is possible.
A number of medical procedures have been developed to aid in the detection, reduction, and elimination of such blockages. An angiogram is one technique for detecting the extent of a blockage. A common type of angiogram allows the visualization of the blood in the arteries. To perform the angiogram, a diagnostic catheter is used to administer the X-ray contrast agent in the area to be visualized. Distribution of the contrast agent within the arteries allows X-ray visualization of the size of the artery openings.
Once a narrowing or blockage has been identified using an angiogram, a separate procedure is then used for treatment. A balloon angioplasty is a common method for treating a narrowing or blockage by mechanically widening the blood vessel. A balloon angioplasty must be performed using a separate catheter from the diagnostic catheter used to perform the initial angiogram.
A similar procedure known as a venogram can be used to diagnose and treat disorders of the veins. The present invention, as will be described below, can be used in connection with both angiograms and venograms. For the purposes of clarity in the following description it will be understood by those of skill in the art that references to angiograms or angioplasty will apply with equal effectiveness to venograms.
Multiple angiograms and angioplasties may be needed when the narrowing or blockage is extensive. As a result, an extensive procedure would require the use of multiple catheters to separately perform the angiogram and the angioplasty. Furthermore, having to exchange the diagnostic catheter and the balloon catheter to perform each procedure can increase the duration of the overall procedure. Exchanging between a diagnostic catheter and a balloon catheter during a procedure may also lead to various health complications.
Bleeding is one risk associated with catheterization. There is a general risk of bleeding anytime the skin is pierced. The risk of severe bleeding increases at the site where the catheters are inserted. Accordingly, removal and insertion of catheters may result in greater blood loss.
Infections are another risk associated with catheterization. The removal and insertion of multiple catheters into a lesion increases the risk of exposing harmful bacteria and agents into the bloodstream.
Arteries and veins generally travel along with nerves. There is a risk of injuring nerves when a catheter is inserted across a lesion. Such nerve injury may lead to numbness. Although such injury is not necessarily fatal, it can lead to much discomfort. Inserting and re-inserting separate catheters may increase the risk of damaging a nerve.
Injury to blood vessels is a more serious risk associated with catheterization. Complications, such as torn blood vessels, can unnecessarily risk the health of the patient and may require surgery, which increases the costs and risks to the patient. Moreover, patents may also experience increased swelling or bruising at points where the catheters were inserted. Removing and re-inserting individual catheters for angiograms and angioplasties can increase these risks.
Inserting catheters across the same lesion becomes increasingly difficult with each subsequent attempt. Accordingly, exchanging catheters increases the risk of losing access across the lesion. This further contributes to unnecessary delay and increased risks to the patient.
Therefore, it is the object of the present invention to combine the attributes of a diagnostic angiogram catheter with a balloon angioplasty catheter, so that a single catheter can facilitate both procedures. In doing so, the present invention helps reduce or eliminate the complications associated with having to use separate catheters to perform angiograms and angioplasties.
The use of a single catheter also results in a significant time savings for the completion of the surgical process. This is beneficial for a number of reasons. Shortening the time that the patent is undergoing surgery reduces the chance of infection or other complications, and promotes healing. A surgeon is able to treat more patients in a given time period. This increases efficiencies and reduces the cost of patient care.